FDA Device recall Z-0633-2021
HLS Set Advanced, Model: BEQ-HLS 7050 USA
- FDA Device
- Class II
- terminated
- Published 2020-12-23
On 2020-12-23 the FDA classified a Class II recall of HLS Set Advanced, Model: BEQ-HLS 7050 USA by Maquet Cardiovascular Us Sales, citing the HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0633-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-20 |
| Published | 2020-12-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Maquet Cardiovascular Us Sales |
| Distribution | US |
Product
HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
Reason
The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
Identifiers
| code_info | Model Number: BEQ-HLS 7050 Part Number: 70105.2794 UDI Code: 04037691773513 Lot Codes: 70130364, 70132269, 70133476,…Model Number: BEQ-HLS 7050 Part Number: 70105.2794 UDI Code: 04037691773513 Lot Codes: 70130364, 70132269, 70133476, 70133592, 70133623, 70133624, 70133625, 70134790, 70135038 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0633-2021%22
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